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NCT02717949 · ClinicalTrials.gov registry record · Phase 4
Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT02717949 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT02717949, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
There still remains the question if hepatitis C eradication with all oral therapy will lead to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate with a reduction of the size and extent of low-grade lymphoma. The hypothesis of this study is that subjects with hepatitis C,regardless of genotype, who have low grade lymphoma, when treated for hepatitis C without pegylated interferon will have a regression of low grade non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a subset of HCV-related low grade B cell non-Hodgkin's lymphoma Primary Objective This study will assess the safety, as measured by adverse events, in subjects receiving hepatitis C treatment. Secondary Objective The secondary objective of this study is to assess the rate of overall response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete response according to revised international working group criteria for non-Hodgkin lymphoma. Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and serious adverse events. In addition, the study will assess the number of subjects who had to stop treatment due to adverse events or serious adverse events. The study will also examine the number of subjects in which treatment for lymphoma had to be given due to clinical progression. Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or complete response according to revised international working group criteria for non-Hodgkin lymphoma. (2) Determine the rate of sustained viral response in subjects
Interventions
- DRUG Ribavirin
- DRUG sofosbuvir/ledipasvir
- DRUG sofosbuvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-02-25 |
| Est. Completion | 2017-07-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02717949
The ClinicalTrials.gov registry entry for NCT02717949 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT02717949 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02717949 about?
NCT02717949 is a clinical study titled "Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study". There still remains the question if hepatitis C eradication with all oral therapy will lead to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate with a reduction of the ...
What is the current status of trial NCT02717949?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2016-02-25. Estimated completion is 2017-07-18.
What interventions are being tested in trial NCT02717949?
The interventions under investigation include: Ribavirin (DRUG), sofosbuvir/ledipasvir (DRUG), sofosbuvir (DRUG).
Who is sponsoring clinical trial NCT02717949?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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